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OP0109 EFFICACY OF FILGOTINIB VS PLACEBO IN ACTIVE PSORIATIC ARTHRITIS: PATIENT-LEVEL DATA FROM EQUATOR, A RANDOMIZED, PHASE 2 STUDY
  1. Philip J Mease1,
  2. Dafna D Gladman2,
  3. Filip van den Bosch3,
  4. Mykola Stanislavchuk4,
  5. Anna Rychlewska-Hanczewska5,
  6. Chantal Tasset6,
  7. Luc Meuleners6,
  8. Robin Besuyen7,
  9. Jingjing Gao8,
  10. Mona Trivedi8,
  11. Laura C Coates9,
  12. Philip Helliwell10
  1. 1Swedish Medical Center/Providence St Joseph Health and University of Washington, Seattle, United States of America
  2. 2University of Toronto and Krembil Research Institute, Toronto Western Hospital, Toronto, Canada
  3. 3Ghent University Hospital, Ghent, Belgium
  4. 4National Pirogov Memorial Medical University, Vinnytsya, Ukraine
  5. 5Ai Centrum Medyczne, Poznan, Poland
  6. 6Galapagos NV, Mechelen, Belgium
  7. 7Galapagos BV, Leiden, Netherlands
  8. 8Gilead Sciences, Inc., Foster City, United States of America
  9. 9University of Oxford, Oxford, United Kingdom
  10. 10Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom

Abstract

Background Filgotinib (FIL) is an oral, selective Janus kinase 1 inhibitor in development for the treatment of several inflammatory diseases. In the phase 2 EQUATOR trial (NCT03101670), FIL was efficacious vs placebo (PBO) in patients with active psoriatic arthritis (PsA), and was well tolerated [1].

Objectives To evaluate the onset and maintenance of response to FIL vs PBO in EQUATOR by evaluating patient–level response over time.

Methods EQUATOR was a 16-week, multicenter, double-blind study in which patients with active PsA were randomized 1:1 to FIL 200 mg or PBO once daily [1]. Disease activity was assessed at screening, day 1 and weeks 1, 2, 4, 8, 12 and 16, and the primary efficacy endpoint was the proportion of patients achieving 20% American College of Rheumatology (ACR20) response. The onset of response was assessed by calculating the median time to ACR20 response using the Kaplan-Meier method and compared between FIL and PBO using the log-rank test. Maintenance of response was assessed by analysing ACR20 response patterns over time in the FIL and PBO groups.

Results Of 131 patients randomized (FIL: n=65; PBO: n=66), 124 (95%) completed the study. Demographics and baseline disease characteristics were similar between groups. The onset of response to FIL was early, with a median (95% confidence interval) time to first ACR20 response of 4.07 weeks (2.29, 4.14) in the FIL group compared with 12.29 weeks (12, not reached) in the PBO group (p<0.0001; Figure 1). ACR20 responses were achieved at week 16 in 80.0% (52/65) and 33.3% (22/66) of patients in the FIL and PBO groups, respectively, using the non-responder imputation method, and 86.7% (52/60) and 34.4% (22/64), respectively, using observed cases. The number of patients who presented with a stable ACR20 response (i.e. the response was maintained once initially achieved regardless of the time point at which the patient first became a responder) among those who were responders at week 16 (i.e. the primary endpoint) was higher in the FIL group than in the PBO group (80.8% [42/52] vs 68.2% [15/22]) (Figure 2) Similar trends were observed for other efficacy endpoints representing various manifestations of PsA.

Conclusion In general, patients treated with FIL achieved an ACR20 response earlier than those on PBO and these responses appeared to be more stable. In the PBO group, there were more occurrences of the response being lost over time and fewer cases of regaining a lost response.

Reference [1] Mease P, et al. Lancet2018;392:2367–77.

Acknowledgement This study was funded by Galapagos NV (Mechelen, Belgium). Medical writing support was provided by Alice Wareham PhD, CMPP (Aspire Scientific Ltd, Bollington, UK) and funded by Galapagos NV.

Disclosure of Interests Philip J Mease Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: AbbVie, Amgen, BMS, Galapagos, Gilead Sciences, Inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB, Dafna D Gladman Grant/research support from: AbbVie, Amgen, Celgene, Lilly, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB, Filip van den Bosch Consultant for: AbbVie, BMS, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, BMS, Janssen, Lilly, Merck, Novartis, Pfizer and UCB., Mykola Stanislavchuk Grant/research support from: AstraZeneca, Celltrion, Galapagos, Genentech, GlaxoSmithKline, Human Genome, Lilly, MedImmune, Pfizer, Roche and UCB, Anna Rychlewska-Hanczewska Grant/research support from: Galapagos and Gilead Sciences, Inc., Chantal Tasset Shareholder of: Warrants from Galapagos, Employee of: Galapagos, Luc Meuleners Shareholder of: Warrants from Galapagos, Employee of: Galapagos, Robin Besuyen Shareholder of: Warrants from Galapagos, Employee of: Galapagos, Jingjing Gao Shareholder of: AbbVie and Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Mona Trivedi Shareholder of: Amgen and Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Laura C Coates Grant/research support from: AbbVie, Celgene, Lilly, Novartis and Pfizer, Consultant for: AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead Sciences Inc., Janssen, Lilly, Novartis, Pfizer, Prothena Corp and UCB, Philip Helliwell Grant/research support from: Paid to charity: from AbbVie, Janssen and Novartis, Consultant for: Paid to charity: from AbbVie, Amgen, Pfizer, and UCB and Celgene. Paid to self: from Celgene and Galapagos

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